Türk Kardiyol Dern Arş - Arch Turk Soc Cardiol 2015;43(2):169-177 doi: 10.5543/tkda.2015.35984

An epidemiological study to evaluate the use of vitamin Kantagonists and new oral anticoagulants among non-valvular

atrial fibrillation patients in Turkey- AFTER*-2 study designTürkiye’de nonvalvüler atriyum fibrilasyonlu hastalarda vitamin K antagonisti ve

yeni oral antikoagülan kullanımı uygulamalarını değerlendirmek içinepidemiyolojik çalışma - AFTER*-2 çalışması dizaynı

Dept. of Cardiology, Dicle University Faculty of Medicine, Diyarbakir; #Dept. of Cardiology, Gaziantep University Faculty of Medicine, Gaziantep; *Dept. of Cardiology, Karadeniz Technique University Faculty of Medicine, Trabzon; †Dept. of Cardiology, Diskapi Training and Research Hospital, Ankara; ‡Dept. of Cardiology, Yuksek

Ihtisas Training and Research Hospital, Ankara; §Dept. of Cardiology, Kosuyolu Training and Research Hospital, Istanbul; ||Dept.of Cardiology, Erciyes University Faculty of Medicine, Kayseri; ¶Dept. of Cardiology, Siyami Ersek Training and Research Hospital, Istanbul; **Dept. of Cardiology, Mehmet Akif Ersoy Training and Research

Hospital, Istanbul; ††Dept. of Cardiology, Bezmialem Foundation University Faculty of Medicine, Istanbul; ‡‡Dept. of Cardiology, Medeniyet University Faculty of Medicine, Istanbul; §§Dept. of Cardiology, Mersin State Hospital, Mersin; ||||Dept. of Cardiology, Bozyaka Training and Research Hospital, Izmir; ¶¶Dept. of Cardiology, Mardin State Hospital, Mardin; ◊Dept. of Cardiology, Akdeniz University Faculty of Medicine, Antalya; ∂Dept. of Cardiology, Dokuz Eylül University Faculty of Medicine, Izmir; ##Dept. of

Cardiology, Yuzuncu Yil University Faculty of Medicine, Van; ΩDept. of Cardiology, Denizli State Hospital, Denizli; ¥Dept. of Cardiology, Cardiology Institute, Istanbul; ∇Dept. of Cardiology, Numune Training and Research Hospital, Adana; ßDept. of Cardiology, Medical Park Hospital, Bursa; ∆Dept. of Cardiology, Cukurova University Faculty of

Medicine, Adana; δDept. of Cardiology, Adnan Menderes University Faculty of Medicine, Aydin; ψDept. of Cardiology, Grand Medical Hospital, Manisa; ϕDept. of Cardiology, Mustafa Kemal University Faculty of Medicine, Hatay; ωDept. of Cardiology, Sakarya University Faculty of Medicine, Sakarya; λDept. of Cardiology, Yuksek Ihtisas Training and Research Hospital, Bursa; σDept. of Cardiology, Firat University Faculty of Medicine, Elazig; ηDept. of Cardiology, Onsekiz Mart University

Faculty of Medicine, Canakkale; ◊◊Dept. of Cardiology, Trakya University Faculty of Medicine, Edirne; ∂∂Dept. of Cardiology, Abant Izzet Baysal University Faculty of Medicine, Bolu; ∇∇Dept. of Cardiology, Harran University Faculty of Medicine, Sanliurfa; ΩΩDept. of Cardiology, Kirikkale University Faculty of Medicine, Kirikkale;

¥¥Dept. of Cardiology, Ondokuz Mayis University Faculty of Medicine, Samsun; σσDept. of Cardiology, Fatih University Faculty of Medicine, Istanbul; ßßDept. of Cardiology, Selcuk University Faculty of Medicine, Konya; ∆∆Dept. of Cardiology, Hitit University Faculty of Medicine, Corum; δδDept. of Cardiology, Kafkas University Faculty of

Medicine, Kars; ψψDept. of Cardiology, Ataturk University Faculty of Medicine, Erzurum; ϕϕDept. of Cardiology, Bulent Ecevit University Faculty of Medicine, Zonguldak;ωωDept. of Cardiology, Mevlana University Faculty of Medicine, Konya; λλDept. of Cardiology, Kastamonu State Hospital, Kastamonu

Faruk Ertaş, M.D., Hasan Kaya, M.D., Abdulkadir Yıldız, M.D., Vedat Davutoğlu, M.D.,# Abdulkadir Kiriş, M.D.,* Lale Dinç, M.D.,†

Habibe Kafes, M.D.,‡ Anıl Avcı, M.D.,§ Bekir Calapkorur, M.D.,|| Gökhan Ertaş, M.D.,¶ Mehmet Gül, M.D.,** Nuray Kahraman Ay, M.D.,†† Serkan Bulur, M.D.,‡‡ Mine Durukan, M.D.,§§ Murat Eren, M.D.,|||| İbrahim İlhan, M.D.,¶¶ Murathan Küçük, M.D.,◊ Ebru Özpelit, M.D.,∂

Hakkı Şimşek, M.D.,## F. Mehmet Uçar, M.D.,Ω Ahmet Yıldız, M.D.,¥ D. Yıldıray Şahin, M.D.,∇ Erkan Ayhan, M.D.,ß C. Emre Çağlayan, M.D.,∆ Hasan Güngör, M.D.,δ Ferhat Özyurtlu, M.D.,ψ Nihat Şen, M.D.,ϕ Bülent Vatan, M.D.,ω Fahriye Vatansever, M.D.,λ Mehmet Ali Kobat, M.D.,σ Ahmet Temiz, M.D.,η Gökay Taylan, M.D.,◊◊ İbrahim Dönmez, M.D.,∂∂ M. Emre Erkuş, M.D.,∇∇ Selami Söylemez, M.D.,ΩΩ Halit Zengin, M.D.,¥¥

Mahmut Gündüz, M.D.,σσ Abdullah Tuncez, M.D.,ßß Yusuf Karavelioğlu, M.D.,∆∆ Tayyar Gökdeniz, M.D.,δδ Yavuzer Koza, M.D.,ψψZiyaeddin Aktop, M.D.,ϕϕ Hüseyin Katlandur, M.D.,ωω Pelin Karaca Özer, M.D.,λλ Murat Yüksel, M.D., Halit Acet, M.D.,

Habib Çil, M.D., Sait Alan, M.D., Nizamettin Toprak, M.D.

Received: January 24, 2015 Accepted: February 16, 2015Correspondence: Dr. Abdulkadir Yildiz. Dicle Üniversitesi Tıp Fakültesi,

Kardiyoloji Anabilim Dalı, 21280 Diyarbakır, Turkey.Tel: +90 412 - 248 80 01 e-mail: drakadiryildiz@gmail.com

© 2015 Turkish Society of Cardiology

169

Objectives: Atrial fibrillation (AF) is one of the most common causes of preventable ischemic stroke and is related to increased cardiovascular morbidity and mortality. There is a lack of data in Turkey on the use of new oral anticoagulants (NOACs), and time in therapeutic INR range (TTR) in vitamin K antagonist users and AF management modality. In this multi-center trial, we aimed to analyze, follow and evaluate the epidemiological data in non-valvular AF patients.Study design: Four thousand one hundred consecutive adult patients from 42 centers with at least one AF attack identified on electrocardiography will be included in the study. Patients with rheumatic mitral valve stenosis and prosthetic valve disease will be excluded from the study. At the end of one year, the patients will be evaluated in terms of major cardiac end points (death, transient ischemic attack, stroke, systemic thromboembolism, major bleeding and hospitalization).Results: First results are expected in June 2015. Data about major cardiovascular end-points will be available in January 2016.Conclusion: The rates and kind of oral anticoagulant use, TTR in vitamin K antagonist users and main management modality applied in non-valvular AF patients will be determined by AFTER-2 study. In addition, the rate of major adverse events (MACEs) and the independent predictors of these MACEs will be detected (AFTER-2 Study ClinicalTrials.gov number, NCT02354456.).

Amaç: Atriyum fibrilasyonu (AF) önlenebilir iskemik inmenin en sık neden-lerinden biri olup artmış kardiyovasküler morbidite ve mortaliteyle ilişkilidir. Ülkemizde yeni oral antikoagülan kullanım sıklığı, vitamin K antagonisti kullanan hastalarda Uluslararası Düzeltme Oranı’nın (INR) etkin düzeyde kalma oranı ve AF tedavi yönetimi ile ilgili büyük bir çalışma mevcut de-ğildir. Bu çok merkezli çalışmada amacımız nonvalvüler AF hastalarında epidemiyolojik verilerin analizi, takibi ve değerlendirilmesidir.Çalışma planı: Kırk iki merkezden elektrokardiyografisinde en az bir defa AF atağı tespit edilmiş ardışık 4100 erişkin hasta çalışmaya alı-nacaktır. Romatizmal mitral darlığı ve protez kapak hastalığı olan AF hastaları çalışmaya alınmayacaktır. Hastalar birinci yılın sonunda majör kardiyak sonlanım noktaları (ölüm, geçici iskemik atak, inme, sistemik tromboembolizm, majör kanama ve hastane yatışı) açısından değer-lendirilecektir.Bulgular: İlk sonuçlar Haziran 2015 yılında bekleniyor. Majör kardiyak sonlanım noktaları açısından veriler Ocak 2016’da elde edilecektir.Sonuç: AFTER-2 çalışması ile ülkemizdeki non-valvüler AF hastaları-nın oral antikoagülan tedavi kullanım sıklığı ve çeşidi, varfarin alan has-talarda etkin INR düzeylerinde kalma oranı ve benimsenen tedavi yöne-timi belirlenecektir. Ayrıca, ülkemizde AF’li hastalarda majör istenmeyen olay sıklığı ve bu olayların bağımsız belirteçleri de ortaya çıkarılacaktır (AFTER-2 Study ClinicalTrials.gov number, NCT02354456).

ABSTRACT ÖZET

*AFTER: Atrial Fibrillation in Turkey: Epidemiologic Registry.

Atrial fibrillation (AF) is the most

common sustained car-diac arrhythmia, with a prevalence of 1-2% in the general population.[1] It is the most common cause of preventable stroke, and strongly associated with increased cardiovascular morbidity and mortality.

The prevalence of AF in Turkey is 1.25%, and its overall morbidity is 6.8/100 person-year according to the national TEKHARF study.[2] The first multi-center trial in AF patients in our country, Atrial Fibrillation in Turkey: Epidemiologic Registry (AFTER) Study, showed that 40% of non-valvular AF patients were on warfarin therapy, with an effective international nor-malized ratio (INR) rate of 37%, and that the most frequent cause of warfarin underuse was physician neglect.[3] However, the use of new oral anticoagu-lants, time in therapeutic INR range (TTR) in warfa-rin users and the main management modality (rhythm or rate control) in AF patients have not been studied in Turkey. In this multi-center trial, we aimed to evaluate the extent of effective anticoagulant use based on a 2012 focused update of the European Society of Car-diology Guidelines for the management of AF, and the epidemiological characteristics of non-valvular AF patients with the use of new oral anticoagulants in clinical practice in addition to the increased aware-ness provided by the AFTER study.

PATIENTS AND METHODS

Study design, sample size

The AFTER-2 study is planned as a prospective, obser-vational and multi-center study with a 1-year patient follow-up. In the anticipation of a total of 86 deaths and 352 events with a death rate of 2.1 and approximately 10.7 combined events per 100 person/year will be nec-essary for the multivariate logistic regression analysis intended to find out the independent predictors of the major adverse events. A total of 4100 patients will be included in the study, reflecting the population of the twelve regions of Turkey according to the Nomencla-ture of Territorial Units for Statistics.

Sample representation

The sample size representing the population of all twelve regions was calculated. Under the leadership of Dicle University Cardiology Department, 42 cen-ters were enrolled in the study after interview and the provision of information on the number of patients they will admit according to the population density of the region. The sample sizes of the regions included in the study are shown in Figure 1. The names of the coordinators and researchers are shown in Table 1.

Trial algorithm

Figure 2 depicts the main steps of the study proto-col. “All consecutive adult non-valvular AF patients applying to the cardiology clinics with at least one attack of AF identified on electrocardiography, and

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Abbreviations:

AF AtrialfibrillationAFTER AtrialFibrillationinTurkey: EpidemiologicRegistryINR InternationalnormalizedratioTTR TimeintherapeuticINRrange

Figure 1. Distribution of the study population according to the Nomenclature of Territorial Units for Statistics.

AFTER-2 Study Design 171

Table 1. The names of the participating researchers and centers with patient number in AFTER-2 study

Name, Surname City Center Patient number

Faruk Ertaş Diyarbakır Dicle University Hospital (Coordinating center) 100Hasan Kaya Diyarbakır Dicle University Hospital (Coordinating center) Abdulkadir Yıldız Diyarbakır Dicle University Hospital (Coordinating center)İbrahim İlhan Mardin Mardin State Hospital 110Vedat Davutoğlu Gaziantep Gaziantep University Hospital 135M. Emre Erkuş Şanlıurfa Harran University Hospital 80Hakkı Şimşek Van Yüzüncüyıl University Hospital 110Yavuzer Koza Erzurum Atatürk University Hospital 60Mehmet Ali Kobat Elazığ Fırat University Hospital 90Tayyar Gökdeniz Kars Kafkas University Hospital 60Ziyaeddin Aktop Zonguldak Bülent Ecevit University Hospital 55Pelin Karaca Özer Kastamonu Kastamonu State Hospital 50Halit Zengin Samsun 19 Mayıs University Hospital 80Yusuf Karavelioğlu Çorum Hitit University Hospital 70Abdulkadir Kiriş Trabzon Karadeniz Technique University Hospital 135Murathan Küçük Antalya Akdeniz University Hospital 110D. Yıldıray Şahin Adana-1 Numune Training and Research Hospital 105Ç. Emre Çağlayan Adana-2 Çukurova University Hospital 100Nihat Şen Hatay Mustafa Kemal University Hospital 100Mine Durukan Mersin Mersin State Hospital 110Hasan Güngör Aydın Adnan Menderes University Hospital 100Ebru Özpelit İzmir-1 Dokuz Eylül University Hospital 110Murat Eren İzmir-2 Bozyaka Training and Research Hospital 110Fatih M. Uçar Denizli Denizli State Hospital 110Ferhat Özyurtlu Manisa Grand Medical Hospital 100Ahmet Temiz Çanakkale 18 Mart University Hospital 90Gökay Taylan Edirne Trakya University Hospital 85Erkan Ayhan Bursa-1 Medical Park Hospital 100Fahriye Vatansever Bursa-2 Yüksek İhtisas Training and Research Hospital 100Anıl Avcı İstanbul-1 Koşuyolu Training and Research Hospital 130Mehmet Gül İstanbul-2 Mehmet Akif Ersoy Training and Research Hospital 120Gökhan Ertaş İstanbul-3 Siyami Ersek Training and Research Hospital 120Serkan Bulur İstanbul-4 Medeniyet University Hospital 110Ahmet Yıldız İstanbul-5 Cardiology Institute 110Nuray Kahraman Ay İstanbul-6 Bezmialem University Hospital 110Mahmut Gündüz İstanbul-7 Fatih University Hospital 70Bülent Vatan Sakarya Sakarya University Hospital 100İbrahim Dönmez Bolu İzzet Baysal University Hospital 80Habibe Kafes Ankara-1 Yüksek İhtisas Training and Research Hospital 130Lale Dinç Ankara-2 Dışkapı Training and Research Hospital 130Abdullah Tuncez Konya Selçuk University Hospital 70Hüseyin Katlandur Konya Mevlana University Hospital 50Bekir Çalapkorur Kayseri Erciyes University Hospital 125Selami Söylemez Kırıkkale Kırıkkale University Hospital 80

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ischemic attack, stroke, systemic thromboembolism, major hemorrhage and hospital admission. In addi-tion, management strategy and medications used will be assessed. Patient inclusion in the study will start in January 2015, and the date of achievement of the targeted number of patients will be the end date.

Definitions and measurements

The patients will be assessed in terms of basic demo-graphic data and medical treatments. A cardiologist will perform the patient evaluation and the data ob-tained will be recorded in a patient registration form prepared for the study. Stroke risk will be assessed by CHA2DS2-VASc score and bleeding risk by the HAS-BLED score.[5,6] An echocardiographic examination of all patients will be performed to determine the di-ameters and ejection fraction of the left heart. Routine total blood count parameters, INR values, biochemi-cal profile of the patients will be performed in each center’s own laboratory. Assuming that changes be-tween consecutive INR measurements (at least 6) are linear over time, the percent of time in therapeutic INR range will be calculated according to the Roos-endaal method.[7] Target TTR level will be accepted as >60%, as the guidelines recommend.

According to International Society on Thrombosis and Hemostasis criteria, major bleeding is defined as that causing a fall in hemoglobin level of at least 2 g per deciliter, leading to transfusion of two or more units of whole blood or red cell, symptomatic bleed-ing in a critical area or organ, (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome) and/or fatal.[8]

Statistical analysis

Data will be analyzed with the Statistical Package for the Social Sciences (SPSS) software version 13.0 for Windows (SPSS Inc, Chicago, IL). The Kolmogorov- Smirnov test will be used to verify the normality of distribution of continuous variables. Continuous variables will be defined as mean ± standard devia-tion if data show normal distribution; and as median (interquartile range) if data show abnormal distribu-tion. Categorical variables will be given as percent-ages. The Student t test or the Mann-Whitney U test will be used in comparison between two groups, and one- sided variance analysis (ANOVA) will be used in the comparison of >2 groups for continuous variables.

without rheumatic mitral valve stenosis or prosthetic valve disease” will be included in the study. Patients who refuse to be a participant or to sign the consent form will be excluded from the study. After signing a consent form, the standard registration form gener-ated in accordance with the guidelines will be filled out for each patient (Suppl. 1).[4]

Ethical considerations

The study was approved by local Ethics Committee (The Ethics Committee of Dicle University; date and number: 26/12/2014-47). Every patient will sign a consent form.

Trial outcomes

Primary outcomes of the study are death, transient

Figure 2. Main steps of the study protocol. AF: Atrial fibrilla-tion; INR: International normalized ratio; TTR: Time in thera-peutic INR range.

AF at least in one ECG

1 year follow up

Final analysis

Rheumatic mitral stenosis Prosthetic heart valve or ring

Registration form CHADsVASc scoreHASBLED score

Anticoagulant typeINR value, TTR analysis

Biochemical and hematologic parametersBasic echocardiographyManagement strategy

DeathTransient ischemic attack

StrokeSystemic thromboembolism

Major hemorrhageHospital admission

Yes

No

Abnormally distributed parameters will be compared using the Mann-Whitney U test and the Kruskal-Wallis test between two groups and >2 groups re-spectively. The Chi-square test will be used for the comparison of qualitative data. The Pearson or Spear-men test will be used in the correlation of variables. A multivariate logistic regression analysis will be used for determination of independent predictors of the primary endpoints, and Kaplan’s graphics and Cox hazard proportional analysis will be used for survival analysis at the end of the study. Statistical significance will be defined as p<0.05.

DISCUSSION

Our previous multi-center AFTER study showed that fewer than half of the anticoagulation indicated non-valvular AF patients were using warfarin therapy, with almost one-third having an effective INR level. In addition, one-fifth of low-risk patients were using warfarin although it was not indicated according to the guidelines.[3]

With respect to the guideline recommendations, detailed characteristics of the patients with non-val-vular AF, the rates and kind of oral anticoagulant use, the effect of increased awareness and NOACs on anti-coagulant use rate, TTR in warfarin-using patients and the bleeding risks of the patients will be determined in this study. At the end of the study, we will question the patients in terms of major adverse events and analyze the independent predictors of these events. In addition to making a contribution to the literature, the data will then be channeled into clinical practice.

Conflict-of-interest issues regarding the authorship or article: None declared

REFERENCES

1. Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, et al. Prevalence of diagnosed atrial fibrillation in adults:

national implications for rhythm management and stroke pre-vention: the AnTicoagulation and Risk Factors in Atrial Fi-brillation (ATRIA) Study. JAMA 2001;285:2370-5. CrossRef

2. Uyarel H, Onat A, Yüksel H, Can G, Ordu S, Dursunoğlu D. Incidence, prevalence, and mortality estimates for chronic atrial fibrillation in Turkish adults. Turk Kardiyol Dern Ars 2008;36:214-22. [Article in Turkish]

3. Ertas F, Eren NK, Kaya H, Aribas A, Acar G, Kanadasi M, et al. The atrial fibrillation in Turkey: Epidemiologic Registry (AFTER). Cardiol J 2013;20:447-52. CrossRef

4. Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohn-loser SH, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. De-veloped with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012;33:2719-47. CrossRef

5. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thrombo-embolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010;137:263-72. CrossRef

6. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrilla-tion: the Euro Heart Survey. Chest 2010;138:1093-100. CrossRef

7. Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E. A method to determine the optimal intensity of oral anticoagu-lant therapy. Thromb Haemost 1993;69:236-9.

8. Schulman S, Kearon C; Subcommittee on Control of Anti-coagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of an-tihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005;3:692-4. CrossRef

AFTER-2 Study Design 173

Key words: Anticoagulant agent; atrial fibrillation/epidemiology; drug utilization; electrocardiography; international normalized ratio; war-farin.

Anahtar sözcükler: Antikoagülan ilaç; atriyum fibrilasyonu/epide-miyoloji; ilaç kullanımı; elektrokardiyografi; uluslararası düzeltme oranı; varfarin.

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Protocol No

Hospital

Date

Barcode

Name-Surname

Republic ID No

Tel 1

Tel 3

Age

Weight

Blood Pressure Syst: Diast:

Job

Tel 2

Tel 4

Gender

Height

Heart Rate

(1) Every patient who presents with AF for the first time is considered a patient with first diagnosed AF, irrespective of the duration of the arrhythmia or the presence and severity of AF-related symptoms. (2) Paroxysmal AF is self-terminating, usually within 48 h. Although AF paroxysms may continue for up to 7 days, the 48 hr time point is clinically important(3) Persistent AF is present when an AF episode either lasts longer than 7 days or requires termination by cardioversion, either with drugs or by direct current cardioversion (4) Permanent AF is considered when the presence of the arrhythmia is accepted by the patient (and physician). Thus, rhythm control interventions are, by definition, not pursued in patients with permanent AF. Should a rhythm control strat-egy be adopted, the arrhythmia is redesignated as ‘longstanding persistent AF’.

AF TYPE

First Diagnosed AF Paroxysmal Persistant Permanent

Suppl. 1: AFTER-2 Study-Patient Registration Form

EHRA I ‘No symptoms’

EHRA II ‘Mild symptoms’; normal daily activity not affected

EHRA III ‘Severe symptoms’; normal daily activity affected

EHRA IV ‘Disabling symptoms’; normal daily activity discontinued

EHRA SCORE

Coronary Artery Disease

Ischemic Cardiomyopathy (CMP)

Dilated CMP

Hypertrophic CMP

Chronic Obstructive Lung Disease

Deep Vein Thrombosis

Pulmonary Thromboemboli

Thyrotoxicosis

Chronic Kidney Disease

Smoking

COMORBID SITUATIONS

AFTER-2 Study Design 175

HASBLED SCORE Point

H Hypertension 1

A Abnormal Kidney tests 1

Abnormal Liver tests 1

S Stroke 1

B Bleeding 1

L Labile INRs 1

E Elderly (>65) 1

D Drug 1

Alcohol 1

Total Point

“Hypertension” is defined as systolic blood pressure >160 mmHg. No point is given to the controlled HT“Abnormal kidney function” is defined as the presence of chron-ic dialysis or renal transplantation or serum creatinine ≥ 2.3mg/dl “Abnormal liver function” is defined as chronic hepatic disease (e.g. cirrhosis) or biochemical evidence of significant hepatic derangement (e.g. bilirubin .2 x upper limit of normal, in association with aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase .3 x upper limit normal, etc.)“Bleeding” refers to previous bleeding history and/or predisposi-tion to bleeding, e.g. bleeding diathesis, anaemia, etc.“Labile INRs” refers to unstable/high INRs or poor time in thera-peutic range (e.g. <60%).“Drugs/alcohol use” refers to concomitant use of drugs, such as antiplatelet agents, non-steroidal anti-inflammatory drugs, or alcohol abuse, etc.

CHA2DS2VASc SCORE Point

C Congestive Heart Failure/LV Dysfunction (EF<%40) 1

H Hypertension 1

A Age ≥75 2

D Diabetes Mellitus 1

S Stroke, TIA, Tromboemboli 2

V Vascular disease (MI, PAH, Aortic plaque) 1

A Age 65-74 1

S Sex Category 1

Total Point

Hb (g/dl)

MPV

Htc (%)

RDW

PLT (x1000)

PDW

WBC (x1000)

Platecrit

Neutrophil (%)

Lymphocyte (%)

Monocyte (%)

Glucose

Urea

Creatinine

ALT

AST

GGT

Albumin

T.cholesterol

Trygliceride

LDL

HDL

Uric acid

Ind. Bilirubine

T. Bilirubine

HEMATOLOGICAL PARAMETERS BIOCHEMICAL PARAMETERS

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LA volume = (0.85 x A1 x A2 / L

A1 = LA area apical 4-chamber (A-4C)

A2 = LA area apical 2-chamber (A-2C)

L = shorter LA length from mid plane of mitral anulus to superior LA from either A-4C or A-2C

ECHO PARAMETERS

EF (%)

LA diameter (mm)

LA volume (mm3)

LA thrombus history

Date (day/month/year) INR Mean daily warfarin dosage (mg)

CONSECUTIVE INR VALUES FOR TTR CALCULATION

Pradaxa 110 mg Pradaxa 150 mg Period (month):

Xarelto 15 mg Xarelto 20 mg Period (month):

Eliquis 2.5 mg Eliquis 5 mg Period (month):

NEW ORAL ANTICOAGULANT (NOAC) USE AND USAGE PERIOD (IF ANY)

ASA Prasugrel

Clopidogrel Ticagrelor

ANTIAGGREGANT USE (IF ANY)

B-blocker = Amiodarone

Diltiazem Propofenon

Verapamil Sotalol

Digoxin Other

RHTYHM DRUGS USE (IF ANY)

ACEI = Diuretics =

ARB = Nitrate =

Nifedipine Alfa-blocker =

Digoxin PPI=

Statin = Other

OTHER DRUGS (IF ANY)

AFTER-2 Study Design 177

High bleeding risk (HASBLED)

Neuropsychiatric disorders (Demans, Alzheimer, Anxiety, Depression)

Fall risk

History of bleeding episodes

Peptic ulcus disease

Intracranial aneurysms

Refusal of the patient

Socioeconomic problems (where they live, the lack of follow-up opportunity, educational status)

Physician neglect

Physician choice due to teh advanced age of patient

First diagnosed AF

1. WHAT WAS THE REASON OF NOT TO USE ANTICOAGULANTS IN THE PATIENT?

Rate control

Rhthym control (please answer the following questions)

Medical cardioversion was previously applied. Current treatment?

Electrical cardioversion was previously applied. Current treatment?

AF ablation was previously applied. Current treatment?

Rhyhym control was previously applied, recurrent AF was detected. Current treatment?

LA appendage closure. Which method?

4. WHAT IS THE MANAGEMENT STRATEGY APPLIED TO THE PATIENT?

3. IS THERE ANY SWITCH FROM NOACs TO WARFARIN OR VICE VERSA? WHY?

Distrust as they are new

Because of the cost

Contraindicated

Physician choice

Obligation of warfarin use before NOACs to be paid by social insurance system

2. ALTHOUGH NOACS ARE RECOMMENDED AS THE 1ST CHOICE BY THE GUIDELINES, WHY WERE THE PATIENTS NOT PRESCRIBED NOACS?